VA must improve tracking of surgical implants

Roscoe Butler, American Legion Assistant Director for Health Care, testifies before the House Veterans’ Affairs subcommittee on oversight and investigations. (Photo by Craig Roberts)

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At a Jan. 15 congressional hearing, The American Legion testified on the Department of Veterans Affairs tracking system for surgical implants. The Legion also addressed VA’s practice of allowing vendors into its operating rooms, and the Veterans Health Administration’s (VHA) habit of circumventing the Federal Supply Schedule.

The Legion’s testimony was presented by its assistant director for health care, Roscoe Butler, before the House Veterans’ Affairs subcommittee on oversight and investigations.

“There are several problems with VHA policies and implementation of implant medicine healthcare,” Butler told the subcommittee. “Most of these problems could be fixed with clear written directions from (VA) Central Office, and better oversight and consequences to enforce compliance.”

The American Legion believes that VA still has a problem tracking surgical implants, and until it is fixed veterans remain at risk. An audit made by VA’s Office of Inspector general two years ago identified expired surgical devices on VA supply shelves. The Government Accountability Office has also indicated that VA has an inaccurate tracking capability in recording the serial numbers of implant surgical devices.

“The grave concern to The American Legion is that, in addition to having expired products on the shelves, veterans potentially could be walking around today with expired surgical implants,” Butler said.

The American Legion is urging Congress to require VA to implement an automated tracking system that (1) initially records the serial number of a surgical implant device when procured and placed into VA’s inventory, (2) records the expiration date and (3) alerts VA staff when the product is near its expiration date. The Legion wants VA to accelerate its timeline for implementing a new Prosthetic Inventory System that includes these components; it also wants VA to verify that no veterans currently have expired surgical implants.

The Legion remains concerned that VA does not have an official policy on the presence of vendors in its operating rooms (ORs). While having vendors in ORs to provide technical advice may be medically necessary, it needs to be made clear that veterans have consented to their presence, and have received full disclosure that strictly adheres to a clearly delineated VA policy.

VA has admitted that they do not have a specific policy regarding vendors in ORs, but has indicated that the presence of vendors in the operating room is a common practice in U.S. health care when there are broadly accepted professional ethics standards pertaining to a particular practice,

“VA does not typically reiterate those standards in VA policy,” Butler said. “Rather, it was buried in VA’s Consent Form - 10-0431a - under the vague heading, ‘15. Additional Information,’ which states, in part, the (vendor) representative may provide technical advice but not participate in the procedure.”

Responding to a question of whether vendors who touch patients in ORs should have their contracts terminated, Butler said that, if there aren’t any provisions that address such an instance, “there needs to be something, because that’s a violation of what the veteran consents (to). Based upon the current consent form, the veterans (does) not consent for the vendor to participate in the surgery. So, clearly, that’s a violation of the agreement between the veteran and the clinician.”

The Legion also expressed its concern about VHA making a regular practice of circumventing the Federal Supply Schedule, which exists for good reason. Vendors on the schedule have been carefully vetted, and many of them have important contracts with veteran and/or service-disabled veteran-owned small businesses.

While the Legion recognizes the need to go off schedule in rare circumstances for the medical interests of the patients, it has become increasingly concerned that off-schedule purchases seem to be more the norm than the exception.

The medical health of the veteran is the single most important factor in any decision about health care in the VA system. The Legion’s System Worth Saving site visits to VA medical centers have identified doctors who chose to go off schedule to order stints for heart surgery, because they were uncomfortable with the durability and safety of the stints on the schedule.

“If doctors are constantly going off schedule,” Butler said, “then either the schedule needs to be reformed or the process reformed. No system that is based on circumventing its own processes can be considered in anyone’s best interest.”

LLOYD HAUKOM

I have 4 surgical implants ( 3 neuro stimulators, and 1 morphine pump. These are all for my service connected problems with my back lumbar vertebrae and all of my cervical vertebrae. In all cases, the product vendors were allowed in the OR. I operate the 3 stimulators with a device I carry with me at all times. The morphine pump is refilled and controlled by my physician. I carry cards with all the information that would be needed for any doctor to access. These devices are for me to control my pain for the rest of my life. All were installed by my civilian doctor who along with the vendor has all the model no., serial no., and install dates. Guess maybe I don't understand the problem.